Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer
Sequoia
Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Metastatic Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen
4 other identifiers
interventional
567
12 countries
126
Brief Summary
To compare the efficacy of pegilodecakin in combination with FOLFOX versus FOLFOX alone in participants with metastatic pancreatic cancer as measured by overall survival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pancreatic-cancer
Started Mar 2017
126 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2016
CompletedFirst Posted
Study publicly available on registry
October 5, 2016
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2020
CompletedResults Posted
Study results publicly available
October 19, 2020
CompletedOctober 19, 2020
April 15, 2020
2.5 years
September 30, 2016
August 14, 2020
September 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
Overall survival is defined as the time from date of randomization to the date of death (due to any cause). For participants whose last known status is alive at the data cutoff date for the analysis, time will be censored as the last contact date prior to the data cutoff date.
Randomization to date of death from any cause (Up To 30 Months)
Secondary Outcomes (5)
Progression Free Survival
Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] That Assessed by Investigator
Randomization to PD (Up To 30 Months)
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR)
Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up To 30 Months)
Duration of Response (DOR)
Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)
Percentage of Participants Alive at 1 Year (12-Month Survival Rate)
From randomization to until the date of first documented date of death from any cause within 12 months
Study Arms (2)
Pegilodecakin + FOLFOX
EXPERIMENTALPegilodecakin 5 microgram per kilogram (μg/kg) dosed as one of the following 2 fixed doses: 0.4 milligram (mg) for participants weighing ≤80 kg or 0.8 mg for participants weighing\>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX \[dl-Leucovorin (dl-LV) 400 milligram per meter square (mg/m2) and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2\] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression \[that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity\], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing\>80 kg.
FOLFOX
ACTIVE COMPARATORFOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.
Interventions
Pegilodecakin plus FOLFOX
Eligibility Criteria
You may qualify if:
- The presence of metastatic pancreatic adenocarcinoma
- Measurable disease per RECIST v.1.1
- Participant must have documented tumor progression during or following a gemcitabine containing regimen to treat metastatic disease as established by CT or MRI scan
- Eastern Cooperative Oncology Group Performance Status of 0 - 1
- Participant must have completed prior chemotherapy at least 2 weeks (washout period) prior to randomization and recovered from toxicity to Grade 1 or baseline
- Participants must not have received previous radiation therapy or investigational therapy for the treatment of advanced metastatic disease.
- Participants having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study
- No peripheral neuropathy
- No known history of dihydropyrimidine dehydrogenase deficiency
You may not qualify if:
- Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non- adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma
- Participant on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with half-life of less than 24 hours.
- Participant has received prior treatment with pegilodecakin or fluoropyrimidine/platinum containing regimen
- Participants who were intolerant of a gemcitabine containing regimen.
- History of positivity for human immunodeficiency virus
- Chronic active or active viral hepatitis A, B, or C infection
- Clinically significant bleeding within two weeks prior to randomization (e.g., gastrointestinal (GI) bleeding, intracranial hemorrhage)
- Pregnant or lactating women
- Participants with a history of immune-mediated neurological disorders such as multiple sclerosis, Guillain-Barré or inflammatory CNS/PNS disorders
- Clinically significant ascites defined as requiring ≥ 1 paracentesis every 2- weeks
- Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy),within 28 days prior to randomization or anticipated surgery during the study period
- Prior history of receiving immune modulators including, but not limited to, anti-CTLA4, anti-PD1, anti-PD-L1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- ARMO BioSciencescollaborator
Study Sites (130)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Cancer Treatment Centers of America
Goodyear, Arizona, 85338, United States
University of Arizona Cancer Center
Phoenix, Arizona, 85004, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
St. Joseph Heritage Healthcare
Fullerton, California, 92935, United States
USC Norris Cancer Hospital
Los Angeles, California, 90033, United States
TRIO - Translational Research in Oncology-US, Inc.
Los Angeles, California, 90095, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
Cancer Care Associates Medical Group
Redondo Beach, California, 90277, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Lynn Cancer Institute Ctr for Hem-Onc
Boca Raton, Florida, 33486, United States
Memorial Regional Hospital/Joe Dimaggio Childrens Hospital
Hollywood, Florida, 33021, United States
Baptist Cancer Institute
Jacksonville, Florida, 32207, United States
Watson Clinic
Lakeland, Florida, 33805, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
UF Health Cancer Center- Orlando Health
Orlando, Florida, 32806, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, 30607, United States
Southeastern Regional Medical Center
Newnan, Georgia, 30265, United States
Saint Alphonsus Regional Medical Center
Caldwell, Idaho, 83605, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Fort Wayne Oncology & Hematology
Fort Wayne, Indiana, 46815, United States
St. Elizabeth Medical Center
Edgewood, Kentucky, 41017, United States
Norton Cancer Institute
Louisville, Kentucky, 40202, United States
Hematology Oncology Clinic
Baton Rouge, Louisiana, 70808, United States
New England Cancer Specialists - Scarborough
Scarborough, Maine, 04074, United States
Committee on Clinical Investigations (CCI)- Beth Isreal Deaconess Medical Center IRB
Boston, Massachusetts, 02215, United States
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407, United States
St Louis Cancer Care
Bridgeton, Missouri, 63044, United States
Summit Medical Group
Summit, New Jersey, 07902, United States
North Shore Hematology Oncology Associates
East Setauket, New York, 11733, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Novant Health, Oncology Research Institute
Winston-Salem, North Carolina, 27103, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73190, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232-1305, United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, 37203, United States
Tennessee Oncology PLLC
Nashville, Tennessee, 37203, United States
Texas Oncology-Austin Midtown
Austin, Texas, 78705, United States
Texas Oncology-Plano East
Plano, Texas, 75075, United States
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, 78240, United States
US Oncology
The Woodlands, Texas, 77380, United States
Hope Cancer Center of East Texas
Tyler, Texas, 75701, United States
Texas Oncology - Tyler
Tyler, Texas, 75702, United States
Texas Oncology-Wichital Falls Texoma Cancer Center
Wichita Falls, Texas, 76310, United States
University of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
Virginia Cancer Institute
Richmond, Virginia, 23230, United States
Medical Oncology Associates, PS
Spokane, Washington, 99208, United States
MultiCare Regional Cancer Center - Auburn
Tacoma, Washington, 98002, United States
Aurora West Allis Medical Center
Green Bay, Wisconsin, 54308, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
St Vincent's Hospital
Sydney, New South Wales, 2010, Australia
Warringal Private Hospital
Heidelberg, Victoria, 3084, Australia
Cabrini Hospital Malvern
Malvern, Victoria, 3144, Australia
St John of God Murdoch Hospital
Murdoch, Western Australia, 6150, Australia
Universitätsklinikum Graz
Graz, Styria, 8036, Austria
KH der Barmherzigen Schwestern Linz BetriebsGesmbH
Linz, Upper Austria, 4010, Austria
Universitätsklinikum Salzburg
Salzburg, 5020, Austria
Imeldaziekenhuis
Bonheiden, 2820, Belgium
Hospital Universitaire Erasme Brussel
Brussels, 1070, Belgium
Universitair Ziekenhuis Brussel
Brussels, 1090, Belgium
Grand Hopital de Charleroi-Site Notre-Dame
Charleroi, 6000, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
Clinique St Elisabeth Namur
Namur, 5000, Belgium
CHU Dinant Godinne - UCL Namur
Yvoir, 5530, Belgium
Toronto Sunnybrook Regional Cancer Center
Toronto, Ontario, M4N 3M5, Canada
McGill University
Montreal, Quebec, H3A 1A1, Canada
CHU de Besancon Hopital Jean Minjoz
Besançon, 25030, France
Hopital de la Pitie Salpetriere
Paris, 75651, France
CHU la Miletrie
Poitiers, 86021, France
Hôpital Nord Franche-Comté
Trévenans, 90400, France
Städtisches Klinikum München
München, Bavaria, 81737, Germany
Kliniken Essen-Mitte Ev. Huyssens-Stiftung
Essen, North Rhine-Westphalia, 45136, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, 01307, Germany
Charité Universitätsmedizin Berlin
Berlin, 13353, Germany
St Josef-Hospital Bochum
Bochum, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Asklepios Klinik Altona
Hamburg, 22763, Germany
Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori
Meldola, Forli, 47014, Italy
Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro
Candiolo, Torino, Italy
Ospedale le Torrette
Ancona, 60100, Italy
Azienda Ospedaliera Universitaria Ospedale San Martino di Genova
Genova, 16132, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Ospedale Niguarda Ca Granda
Milan, 20162, Italy
AOU dell'Università degli Studi della Campania Luigi Vanvitelli
Naples, Italy
Istituto Oncologico Veneto
Padua, 35128, Italy
Policlinico San Matteo
Pavia, 27100, Italy
Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia
Reggio Emilia, 42123, Italy
Universita Campus Biomedico
Roma, 00155, Italy
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
Szp.Kliniczny Przemienienia Panskiego UM im.K.Marcinkowskieg
Poznan, 60-569, Poland
Centrum Medyczne Medyk
Rzeszów, 35-025, Poland
Wojewodzki Szpital Zespolony
Torun, 87-100, Poland
Dong-A University Medical Center
Busan, Busan Gwang'yeogsi, 49201, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, 519-809, South Korea
Severance Hospital Yonsei University Health System
Seoul, Korea, 03722, South Korea
Samsung Medical Center
Seoul, Korea, 06351, South Korea
Seoul St. Mary's Hospital
Seoul, Korea, 06591, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Hospital Duran I Reynals
Hospitaled de Llobre, Barcelona, 08907, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, La Coruna, 15706, Spain
Hospital General Universitario Alicante
Alicante, 03010, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario Germans Trias i Pujol
Barcelona, Spain
Hospital General Yague
Burgos, 9005, Spain
C.H. Regional Reina Sofia
Córdoba, 14001, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Madrid Norte Sanchinarro
Madrid, 28050, Spain
Regional University Hospital in Malaga
Málaga, 29011, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Tri-Service General Hospital
Neihu Taipei, 11490, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Addenbrookes Hospital
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Hammersmith Hospital
Acton, London, W12 0HS, United Kingdom
Velindre Hospital
Cardiff, South Glamorgan, CF14 2TL, United Kingdom
University College London Hospital Foundation Trust
London, Surrey, NW1 2BU, United Kingdom
Guys/St. Thomas Hospital
London, Surrey, SE1 9RT, United Kingdom
Related Publications (1)
Hecht JR, Lonardi S, Bendell J, Sim HW, Macarulla T, Lopez CD, Van Cutsem E, Munoz Martin AJ, Park JO, Greil R, Wang H, Hozak RR, Gueorguieva I, Lin Y, Rao S, Ryoo BY. Randomized Phase III Study of FOLFOX Alone or With Pegilodecakin as Second-Line Therapy in Patients With Metastatic Pancreatic Cancer That Progressed After Gemcitabine (SEQUOIA). J Clin Oncol. 2021 Apr 1;39(10):1108-1118. doi: 10.1200/JCO.20.02232. Epub 2021 Feb 8.
PMID: 33555926DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2016
First Posted
October 5, 2016
Study Start
March 1, 2017
Primary Completion
September 9, 2019
Study Completion
March 5, 2020
Last Updated
October 19, 2020
Results First Posted
October 19, 2020
Record last verified: 2020-04-15
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.